Medical sponge for catheter systems

ABSTRACT

The present disclosure generally relates to systems and medical sponge for cleaning needleless connectors. A medical sponge can include a shaped foam configured to engage a portion of the needless connector and a disinfecting solution applied to the shaped foam. A system can include the medical sponge and a liquid-impermeable pouch in which the medical sponge is separately retained. The medical sponge can include highly-abrasive and highly-conforming foam material in place of wipes or other sponge products. The foam material may be an open-cell micro abrasive material such as melamine foam. The foam material may contain disinfecting solutions such as isopropyl alcohol, chlorhexidine gluconate, or povidone-iodine.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 16/206,002 filed Nov. 30, 2018, which is acontinuation of U.S. Non-Provisional patent application Ser. No.15/498,447, filed Apr. 26, 2017 and patented as U.S. Pat. No.10,166,085, which claims the benefit, under 35 U.S.C. § 119(e), of U.S.Provisional Patent Application No. 62/327,470, filed Apr. 26, 2016, thecontents and substance of which is incorporated herein by reference inits entirety as if fully set forth below.

FIELD OF INVENTION

The present disclosure relates to medical sponge, and more particularly,to an apparatus and method for cleaning needleless connectors, alsoreferred to as ports, in central venous catheter (CVC) systems (alsoknown as central line systems).

BACKGROUND

The development of needleless intravenous (IV) administrative systemsbegan in the 1990s to protect against the spread of blood-borne diseasescontracted from needle stick injuries by utilizing a threaded needlelessconnector. To administer medication to a patient from a syringe or IVbag, a healthcare professional must connect a threaded portion of thesyringe or IV bag to a corresponding threaded portion of the needlelessconnector for the medication to flow through the needleless connectorand into the patient. IV systems evolved to include multiple needlelessconnectors allowing multiple medications to be administered to thepatient without using needles or needing to disconnect existingconnections, thus simplifying medication administration by healthcareprofessionals and reducing patient discomfort.

Unfortunately, improper cleaning of these needleless connectors canresult in harmful pathogens, such as bacteria, growing around theneedleless connector. This growth may be referred to as biofilm.Moreover, when medication is administered, a portion of the pathogen (orassociated biofilm) may be inadvertently transferred into the patient'sbloodstream and may result in an infection. The resulting infection isknown as a bloodstream infection (BSI).

When a patient develops a BSI in an intensive care unit (ICU), theresulting infection may be life-threatening. Protocols, such as the“Scrub the Hub” protocol issued by the Centers for Disease Control(CDC), try to mitigate these infections by recommending that theneedleless connectors be scrubbed for at least 15 seconds using alcoholwipes. However, the effectiveness of this approach is limited.

One limitation is that adherence to the recommend 15 seconds ofscrubbing is not strictly monitored and often leads to some healthcareprofessionals scrubbing for less time, resulting in inconsistent orimproper cleaning of the needleless connector.

Another limitation is that, even if healthcare professionals scrub theneedleless connector for at least 15 seconds, the scrubbing must be donethoroughly to ensure proper cleaning of the threads, grooves, septum, orother intricate features where biofilm can develop.

For example, while scrubbing using an alcohol wipe, sufficient pressureneeds be applied to remove biofilm from the needleless connector. Sincealcohol wipes do not provide an indication when sufficient pressure isbeing applied, healthcare professionals have to guess whether or notthey have applied enough pressure. Moreover, alcohol wipes do notconform to a surface when pressure is applied, so healthcareprofessionals must manually shape the wipe and rely on their dexterityto ensure thorough cleaning of the needleless connector's intricatefeatures.

Attempts have been made to replace wipes with cleaning products or capsthat use a foam material. Such products use a semi-closed hydrophilicpolyurethane medical grade foam. Prior attempts to utilize foam forcleaning needleless connectors have been unsuccessful at being a viablereplacement for wipes. Such foam-based products are designed forcleaning female luers wherein the hydrophilic polyurethane foam isencased in a housing with an open end for inserting female luers.Therefore, such prior designs are not effective at cleaning allneedleless connectors. For example, the prior foam-based designs are notsuccessful in cleaning conventional open lumen stopcock device rimscompared to wipes according to, for example, Holroyd et. al., “Universalintravenous access cleaning device fails to sterilize stopcocks,” AnesthAnalg. 2014 February; 118(2):333-43. Additionally, prior foam-baseddevices are not a viable alternative to wipes because they aresignificantly more expensive than wipes. These and other disadvantagesexist.

There is a need for a more robust medical sponge for cleaning needlelessconnectors that is more robust to operator error, better conforms tointricate features, and provides an indication that sufficient pressureis applied.

SUMMARY

Embodiments of the disclosed technology include systems, methods, andequipment for cleaning needleless connectors by reducing inconsistentcleaning caused by operator error.

Some embodiments disclosed comprise a medical sponge including anopen-cell microabrasive foam, such as, for example,formaldehyde-melamine-sodium-bisulfite foam (i.e., “melamine foam”). Thepresent disclosure also relates to methods for cleaning a needlelessconnector that include, in some embodiments, scrubbing the needlelessconnector in a twisting motion with the medical sponge that has adisinfecting solution applied.

In some embodiments, the medical sponge may be configured to provideaudible feedback to a user when the user scrubs a needleless connectorwith the medical sponge in a twisting motion with an appropriate forceto remove a biofilm that may be present on the needleless connector.

In some embodiments, the foam material may have no linear dimensiongreater than 3 centimeters. The medical sponge may be disposable andpackaged in a liquid-impermeable pouch, and the pouch may be scored orprovide some means for being easily torn open during use. Thedisinfecting solution may contain a 70% isopropyl alcohol solution andmay further contain a chlorhexideine solution, a povidone-iodinesolution, or both.

The medical sponge material may have a block or cube shape.Alternatively, the medical sponge may have a cylindrical shape with ahollow center and an open end such that the medical sponge is configuredto be put over the top of a needleless connector or other system ports(similar to how a cap might be placed over a port) wherein the hollowcenter of the medical sponge has the appropriate dimensions to fit overthe needleless connector or port. For example, given standard dimensionsof a needleless connector, a cylindrical hollow center of the medicalsponge having a diameter of at least 7 millimeters but not more than 8millimeters may be capable of fitting over a needleless connector.

Additional features and advantages are realized through the techniquesof the present disclosure. Other embodiments and aspects of thedisclosed technology are described in detail herein and are considered apart of the claimed embodiments. For a better understanding of thedisclosed embodiments with the advantages and the features, refer to thedescription and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B depict an example medical sponge, according to someembodiments of the present disclosure.

FIGS. 2A and 2B depict an example medical sponge, according to someembodiments of the present disclosure.

FIGS. 3A, 3B, and 3C illustrate usage of an example medical spongeaccording to some embodiments of the present disclosure.

FIG. 4 illustrates data comparing the use of an example medical spongeaccording to some embodiments of the present disclosure versus the useof a wipe.

DETAILED DESCRIPTION

Although example embodiments of the present disclosure are explained indetail herein, it is to be understood that other embodiments arecontemplated. Accordingly, it is not intended that the presentdisclosure be limited in its scope to the details of construction andarrangement of components set forth in the following description orillustrated in the drawings. The present disclosure is capable of otherembodiments and of being practiced or carried out in various ways.

It must also be noted that, as used in the specification and theappended claims, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. Ranges may beexpressed herein as from “about” or “approximately” one particular valueand/or to “about” or “approximately” another particular value. When sucha range is expressed, other exemplary embodiments include from the oneparticular value and/or to the other particular value.

By “comprising” or “containing” or “including” is meant that at leastthe named compound, element, particle, or method step is present in thecomposition or article or method, but does not exclude the presence ofother compounds, materials, particles, method steps, even if the othersuch compounds, material, particles, method steps have the same functionas what is named.

As used herein, the term “medical sponge” may refer to a scrubber or afoam scrubber.

As used herein, the term “needless connector” may refer to a CVC systemport (i.e., system port, or port), a CVC catheter hub (i.e., hub), luer,similar medical equipment, or small-bore connections in hypodermicapplication of medical devices and accessories, such as system port 150,is standardized under ISO 80369-7:2016.

In describing example embodiments, terminology will be resorted to forthe sake of clarity. It is intended that each term contemplates itsbroadest meaning as understood by those skilled in the art and includesall technical equivalents that operate in a similar manner to accomplisha similar purpose. It is also to be understood that the mention of oneor more steps of a method does not preclude the presence of additionalmethod steps or intervening method steps between those steps expresslyidentified. Steps of a method may be performed in a different order thanthose described herein without departing from the scope of the presentdisclosure. Similarly, it is also to be understood that the mention ofone or more components in a device or system does not preclude thepresence of additional components or intervening components betweenthose components expressly identified.

Embodiments of the disclosed technology include systems, methods, andapparatus for cleaning needleless connectors. In particular, certainembodiments provide an apparatus and a method for a low-cost, highlyabrasive, medical sponge for cleaning a variety of IV system ports in ashortened period of time compared to existing methods.

Certain embodiments include a medical sponge composed offormaldehyde-melamine-sodium-bisulfite foam, also known as melaminefoam, that is impregnated with a disinfecting solution. As will beappreciated, melamine foam has several advantages over wipes that aretypically used for cleaning needleless connectors. Melamine foam is moreabrasive and thereby more effective at removing biofilms throughfriction, meaning that needleless connectors may be disinfected in ashorter scrubbing time compared to wipes. Melamine foam is fiberless andthereby will not leave behind fibers like a wipe typically used in thisapplication. Melamine foam is highly conformal and therefore moreeffective at cleaning small crevices such as needleless connectorthreads. Melamine foam has an open cell structure that allows forcapillary forces to draw pathogens up and away from the surface of aneedleless connector, whereas a wipe may spread around and leave behindmaterial. When melamine foam is applied to a needleless connector with atwisting motion producing sufficient friction force to remove biofilms,the frictional force generates an auditory feedback, “squeak”, thatinforms the user that biofilms are being removed. Additionally, the costof a medical sponge composed of melamine foam is comparable in price toa wipe typically used to clean needleless connectors, and in someembodiments, may be capable of cleaning the variety of needlelessconnectors. A medical sponge composed of melamine foam is therefore aviable and more effective replacement to a wipe.

Melamine foam has several advantages over semi-closed hydrophilicpolyurethane foam. Unlike hydrophilic polyurethane foam, melamine foamis more abrasive, more conformal, thus allowing for greater diversity incleaning needleless connectors and components, and provides auditoryfeedback during proper use.

FIGS. 1A, 1B, 2A, and 2B illustrate various embodiments of medicalsponge 100 that are composed of a highly conforming, abrasive, andporous foam material that is impregnated with a disinfecting solution,according to the present disclosure. FIGS. 1A and 1B show an exampleembodiment of a medical sponge 100 having a cylindrical shape with ahollow center 105, a closed end 110, an open end 120, and a length 125.The medical sponge 100 is designed to fit over a needleless connector150 such that when in use, the medical sponge 100 can be configured tomake simultaneous contact with the sides and top of the port 150.Currently, the size of small-bore connections in hypodermic applicationof medical devices and accessories, such as needleless connector 150, isstandardized under ISO 80369-7:2016. Accordingly, the present disclosurecontemplates that the diameter of the hollow center 105 and the length125 may be designed to accommodate needleless connectors 150 meeting theISO standard.

In other embodiments, such as shown in FIGS. 2A and 2B, the medicalsponge 100 may have a cube or block shape. The block shape may be sizedto provide an ergonomic hand grip. For example, the Human EngineeringDesign Data Digest issued by the Department of Defense Human FactorsEngineering Technical Advisory Group in Washington D.C. issued April2000 indicates a medical sponge sized approximately two centimeters inheight and/or length may provide an ergonomic fit to hand grip. Andtests indicate that a medical sponge 100 sized between two and threecentimeters in height and length provides the proper ergonomics toproperly clean a needleless connector.

In certain use cases, a technician or other user of embodiments of thedisclosed medical sponge (e.g., 100 of FIG. 1A, 1B, 2A, or 2B) may pressthe medical sponge 100 against the needleless connector 150 in a mannerresulting in conformal contact between the medical sponge 100 and thesides and the top of the port 150. Embodiments can be configured suchthat a user can twist the medical sponge 100 around the sides of theneedleless connector 150 and that the medical sponge 100 can be scrubbedagainst the top of the needleless connector 150 during use. As will beappreciated, the form-fitting characteristics of the scrubbing device100 can allow the needleless connector 150 to be cleaned, particularlythe threads and the septum. As will be appreciated further, the highlyabrasive foam material, in conjunction with the disinfecting solutionthat is impregnated within the foam material can clean the needlelessconnector 150 and remove bacteria.

FIGS. 3A, 3B, and 3C show usage of an example medical sponge (e.g., 100)according to some embodiments. As shown in FIG. 3A, in some embodiments,a medical sponge 100 can be packaged within a liquid impermeable package305. The user may open the package 305 by tearing along a scored line310, for example. Once open, the user can extract the medical sponge 100from the package 305 and apply the medical sponge 100 to a needlelessconnector 150 in a twisting motion, drawing pathogens into the medicalsponge 100 as shown in FIG. 3B. Once cleaning is complete, the medicalsponge 100 containing the pathogens can be discarded in a trash bin asshown in FIG. 3C. As will be appreciated, various embodiments of amedical sponge 100 having a block shape as depicted in FIGS. 2A and 2B,a cylindrical shape as depicted in FIGS. 1A and 1B, or some other shapemay be used in the manner shown in FIGS. 3A, 3B, and 3C.

FIG. 4 illustrates data from tests using example embodiments of amelamine medical sponge containing a 70% isopropyl alcohol (IPA)solution, as indicated by the “BioSCRUB” data points, and data fromusing non-woven IPA prep pads. Initial tests of present embodimentsindicate the medical sponge foam material may remove at least 50% moreEscherichia coli from a needless connector compared to a non-woven IPAprep pad used under identical STH conditions.

1-20. (canceled)
 21. A medical sponge for cleaning a needlelessconnector, the medical sponge comprising: a shaped foam configured toengage a portion of a needleless connector; and a disinfecting solutionapplied to the shaped foam.
 22. The medical sponge of claim 21, whereinthe shaped foam has a substantially rectangular shape.
 23. The medicalsponge of claim 21, wherein the medical sponge has a height betweenabout 2 cm and about 3 cm and a length between about 2 cm and about 3cm.
 24. The medical sponge of claim 21, wherein the shaped foam has anopen-cell structure.
 25. The medical sponge of claim 24, wherein theopen-cell structure of the shaped foam allows for capillary forces todraw pathogens away from the surface of the needleless connector. 26.The medical sponge of claim 21, wherein the shaped foam includesformaldehyde-melamine-sodium-bisulfate.
 27. The medical sponge of claim21, wherein the medical sponge is sufficiently abrasive to produceaudible feedback when twisted on a portion of the needleless connector.28. The medical sponge of claim 27, wherein the audible feedback isgenerated by a frictional force between the medical sponge and a portionof the needleless connector, thereby indicating sufficient frictionalforce is being generated.
 29. The medical sponge of claim 21, whereinthe medical sponge is a single use accessory.
 30. The medical sponge ofclaim 21, wherein the disinfecting solution is at least one of: 70%isopropyl alcohol, Povidone-Iodine, or Chlorhexidine gluconate.
 31. Themedical sponge of claim 21, wherein the medical sponge is configured tobe twisted around a portion of the needleless connector.
 32. The medicalsponge of claim 21, wherein the medical sponge conforms to at least aportion of the needleless connector.
 33. The medical sponge of claim 21,wherein the medical sponge is configured to simultaneously contact withsides and top of the needleless connector.
 34. A system for cleaning aneedleless connector comprising: the medical sponge of claim 21; and aliquid-impermeable pouch, wherein the medical sponge is separablyretained within the liquid-impermeable pouch.
 35. A system for cleaninga needless connector, the system comprising: a medical sponge configuredto engage a threaded portion of the needleless connector; a disinfectingsolution applied to the medical sponge; and a liquid-impermeable pouch,wherein the medical sponge is separably retained within theliquid-impermeable pouch.
 36. The system of claim 35, wherein themedical sponge is sufficiently abrasive to produce audible feedback whentwisted on a portion of the needleless connector.
 37. The system ofclaim 36, wherein the audible feedback is generated by a frictionalforce between the medical sponge and a portion of the needlelessconnector, thereby indicating sufficient frictional force is beinggenerated.
 38. The system of claim 35, wherein the medical spongecomprises a foam having an open-cell structure.
 39. The system of claim38, wherein open-cell structure allows for capillary forces to drawpathogens away from the surface of the needleless connector.
 40. Thesystem of claim 35, wherein the medical sponge is configured to beconformal to at least a portion of the needleless connector.